IFFGD Vice President, William Norton, submitted the following written comments to Noridian Administrative Services in response to the decision by Noridian to deny Medicare coverage for the Solesta procedure for the treatment of fecal incontinence in adults who fail conservative therapy.

On behalf of the International Foundation for Functional Gastrointestinal Disorders (IFFGD) I am writing to you in regard to the recent decision by Noridian to deny Medicare coverage for the Solesta procedure for the treatment of fecal incontinence in adults who fail conservative therapy.

IFFGD is a nonprofit education and research organization founded in 1991. We are dedicated to improving the lives of people with functional gastrointestinal and motility disorders including fecal incontinence. We ask that you re-consider your current position and allow coverage for this procedure, taking into account the illness experience of patients with chronic symptoms, the burdens they face, and the need for patient access to treatment alternatives.

Fecal incontinence can impact and limit nearly every aspect of an individual’s daily life. The condition imposes burdens not only on those who suffer with it, but also on families and society. Although incontinence can occur in people of all ages, the incidence increases with age. As reported by the NIH State-of-the-Science Statement, “Prevention of Fecal and Urinary Incontinence in Adults,” among the elderly up to 20% of women and 10% of men have fecal incontinence.

The burden of fecal incontinence can become overwhelming, especially when combined with other health challenges. For older people, fecal incontinence can result in nursing home admittance because sufferers and family members have difficulty coping with the problem at home.

Current treatment options are limited, and none are universally effective. Conservative attempts to alter stool consistency or patterns, such as dietary changes, fiber supplements, or antidiarrheal medications may at times provide stop-gap measures of control. Minimally-invasive biofeedback may help some.

More extreme measures include surgical procedures such as anal sphincter repair, which may deteriorate over time; sacral nerve stimulation, which requires an implant; and colostomy, a last resort chosen by some. There is a need for treatment alternatives.

The FDA reviewed safety and effectiveness of Solesta and in May 2011 approved the procedure for the treatment of fecal incontinence in adult patients who fail conservative therapy. We are concerned that denial of Medicare coverage, in the region under Noridian’s jurisdiction, is an added cost burden that will in effect deny access to many patients.

We believe that patients managing chronic conditions like fecal incontinence do best when they work in partnership with their doctors. Accordingly, patients should be allowed to make informed treatment decisions while their doctors exercise clinical judgments based on the unique circumstances of each individual.

Given the needs of patients with fecal incontinence for FDA-approved treatments, we ask that you re-consider your current position and approve coverage reimbursement for Solesta. Thank you for your consideration of our comments.